From
Medscape Today:
The US Food and Drug Administration (FDA) has published its latest quarterly list of drugs to monitor after having identified potential signs of serious risks or new safety information, and
dronedarone (Multaq, Sanofi-Aventis), appears on it for the fifth straight time.
The new watch list covers the first 3 months of 2011. During this span, the FDA detected potential signs of renal impairment and failure for dronedarone, approved in July 2009 to reduce the risk for cardiovascular hospitalization in patients with paroxysmal or persistent atrial fibrillation or atrial flutter. The 4 watch lists covering 2010 reported different potential signals of risk, 3 of which preceded related label changes for the drug this year.
The FDA compiles these quarterly lists based on data collected through its Adverse Event Reporting System (AERS). The FDA cautions that a drug's appearance on the list does not mean that the agency has determined that the drug actually poses the health risk reported through AERS. However, it will study these drugs to determine whether there is a causal link. If a link is established, the agency then would consider regulatory action, such as revising the drug's label, requiring a risk evaluation and mitigation strategy, or gathering more data to better characterize the risk.
In the meantime, physicians should not stop prescribing these drugs, nor should patients stop taking them, according to the FDA.